FDA.reportPublic FDA data

ELLEN HAND SANITIZER

Product NDC
85537-101
Requested package NDC
85537-101-11
11-digit product format
855370101
Labeler code
85537
Product ID
85537-101_33077eab-e687-249d-e063-6394a90a1b6d
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
SPRAY
Route
TOPICAL
Labeler
PT. SUPER HOME PRODUCT INDONESIA
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-18
Substance
ALCOHOL
Active strength
60 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
ELLEN HAND SANITIZER
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL60 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1367692Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33077eab-e686-249d-e063-6394a90a1b6dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85537-101-01ELLEN HAND SANITIZER100 mL in 1 BOTTLE, SPRAYSPRAY1001
85537-101-11ELLEN HAND SANITIZER40 in 1 BOXSPRAY401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85537-101ELLEN HAND SANITIZER (ETHYL ALCOHOL) SPRAY [PT. SUPER HOME PRODUCT INDONESIA]1Current NDC, 2 package rows20250419_33077eab-e686-249d-e063-6394a90a1b6d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 19 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ProClearz Maximum Strength Fungal Shield Brush-on AntifungalTOLNAFTATERooftop Consumer Health, Inc.4d451e87-c25b-49cf-92b8-747b053930c22026-03-02WarningsExact identifier
application number: M005
HAND SANITIZER lsland CoconutALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf3a822-27d2-efef-e063-6294a90a05022026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Cherry BlossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf48a93-345d-b901-e063-6394a90ab41b2026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Cucumber MelonALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf552a4-b8b3-6fe3-e063-6394a90a722a2026-03-01WarningsExact identifier
application number: M005
HAND SANITIZER Watermelon SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA4bf57b6e-c271-b4c6-e063-6394a90a63c62026-03-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLETRIFECTA PHARMACEUTICALS USA LLCe0a2a907-9c3a-4c4e-e053-2995a90abb912026-03-01WarningsExact identifier
application number: M005
FOLUPIA FUNGAL NAIL RENEWALFOLUPIA FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4bcacd53-9446-67ec-e063-6294a90a209e2026-02-27WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.d6f5c6b5-5e56-462f-8c47-7986ce53669d2026-02-25WarningsExact identifier
application number: M005
Lakeim FUNGAL NAIL RENEWAL KitFUNGAL NAIL RENEWAL KITGuangzhou Jingliang Cosmetics Co., Ltd.4b6aae50-b219-beee-e063-6394a90ab4152026-02-22WarningsExact identifier
application number: M005
Hermon Jock Itch spray.MICONAZOLE NITRATE 2%Beautivity LLC4b633528-667a-f34e-e063-6294a90a2b3d2026-02-21WarningsExact identifier
application number: M005
Lakeim Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.4b23c3a6-51da-7875-e063-6394a90a14672026-02-18WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL RENEWALFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.4b113f31-1a82-a3ca-e063-6394a90a32312026-02-17WarningsExact identifier
application number: M005
Hermon Ringworm Antifungal soap.CLOTRIMAZOLE 1%Beautivity LLC48405a7c-14cd-b3a0-e063-6394a90a9fc92026-02-13WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal soap.TEA TREE OIL ANTIFUNGAL SOAPRoyceDerm LLC3a6d1e32-a38b-3dde-e063-6394a90a88f32026-02-13WarningsExact identifier
application number: M005
Happy Nuts Jock Itch PowderMICONAZOLE NITRATESuit Up Brands LLC42e2d9df-6537-b3a1-e063-6394a90a47b72026-02-13WarningsExact identifier
application number: M005
Nail Antifungal TreatmentTOLNAFTATE 1% FUNGI NAILBENM INC.2ea24785-c648-4104-e063-6294a90ab12f2026-02-12WarningsExact identifier
application number: M005
Hermon Ringworm Treatment KitMICONAZOLE NITRATE 2% AND CLOTRIMAZOLE 1%Beautivity LLC4a9d9c6e-0e0f-d539-e063-6294a90acb572026-02-12WarningsExact identifier
application number: M005
PHARMBANNER Antifungal Soothing CreamANTIFUNGAL SOOTHING CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a077685-4177-bc0d-e063-6294a90a461b2026-02-12WarningsExact identifier
application number: M005
PHARMBANNER FUNGAL NAIL RENEWALFUNGAL NAIL RENEWALShenzhen Xinxin Yunhai Technology Co., Ltd.3a08ec6c-03ae-b9e5-e063-6394a90a0afb2026-02-12WarningsExact identifier
application number: M005
PHARMBANNER Tinea Versicolor CreamTINEA VERSICOLOR CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3a095194-c7ea-7f30-e063-6294a90a7ea12026-02-12WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1367692ethanol 60 % Topical SprayPSN33077eab-e686-249d-e063-6394a90a1b6d1
1367692ethanol 0.6 ML/ML Topical SpraySCD33077eab-e686-249d-e063-6394a90a1b6d1
1367692ethanol 60 % Topical SpraySY33077eab-e686-249d-e063-6394a90a1b6d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85537-101-118553701011140 BOTTLE, SPRAY in 1 BOX (85537-101-11) / 100 mL in 1 BOTTLE, SPRAY (85537-101-01) 2025-04-18NoNoCurrent